- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479203
Acute Effects of E-Cigarette Aerosol Inhalation
Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Perelman School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• BMI of 18.5 - 30
Exclusion Criteria:
- Cancer
- HIV
- Mental illness
- Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
- Serious arrhythmias
- Bronchospastic disease
- Upper respiratory tract infection within the past six weeks
- Chronic medication or antibiotics
- Claustrophobia / contraindications for MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy, Non-Smokers
Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)
|
16 two-second-long puffs from a non-nicotinized electronic cigarette.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory Blood-Based Biomarkers
Time Frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values
|
Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy. The outcome measure was expressed as fold increase over pre-vaping values. |
Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values
|
Acute Change in Aortic Pulse Wave Velocity Post-vaping
Time Frame: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.
|
Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta. In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping. |
PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.
|
Change in Femoral Artery Flow-Mediated Dilation Post-Vaping
Time Frame: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.
|
Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
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Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.
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Change in Washout Time Post-Vaping
Time Frame: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
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Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
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Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
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Change in Upslope Post-Vaping
Time Frame: Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
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Tissue oxygen resaturation rate after e-cigarette vaping.
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Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
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Change in Overshoot Post-Vaping
Time Frame: Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.
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Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
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Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.
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Change in Breath Hold Index Post-Vaping
Time Frame: Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.
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Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.
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Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felix W. Wehrli, PhD, University of Pennsylvania
Publications and helpful links
General Publications
- Zamani P, Proto EA, Wilson N, Fazelinia H, Ding H, Spruce LA, Davila A Jr, Hanff TC, Mazurek JA, Prenner SB, Desjardins B, Margulies KB, Kelly DP, Arany Z, Doulias PT, Elrod JW, Allen ME, McCormack SE, Schur GM, D'Aquilla K, Kumar D, Thakuri D, Prabhakaran K, Langham MC, Poole DC, Seeholzer SH, Reddy R, Ischiropoulos H, Chirinos JA. Multimodality assessment of heart failure with preserved ejection fraction skeletal muscle reveals differences in the machinery of energy fuel metabolism. ESC Heart Fail. 2021 Aug;8(4):2698-2712. doi: 10.1002/ehf2.13329. Epub 2021 May 15.
- Langham MC, Caporale AS, Wehrli FW, Parry S, Schwartz N. Evaluation of Vascular Reactivity of Maternal Vascular Adaptations of Pregnancy With Quantitative MRI: Pilot Study. J Magn Reson Imaging. 2021 Feb;53(2):447-455. doi: 10.1002/jmri.27342. Epub 2020 Aug 25.
- Kligerman S, Raptis C, Larsen B, Henry TS, Caporale A, Tazelaar H, Schiebler ML, Wehrli FW, Klein JS, Kanne J. Radiologic, Pathologic, Clinical, and Physiologic Findings of Electronic Cigarette or Vaping Product Use-associated Lung Injury (EVALI): Evolving Knowledge and Remaining Questions. Radiology. 2020 Mar;294(3):491-505. doi: 10.1148/radiol.2020192585. Epub 2020 Jan 28.
- Chatterjee S, Caporale A, Tao JQ, Guo W, Johncola A, Strasser AA, Leone FT, Langham MC, Wehrli FW. Acute e-cig inhalation impacts vascular health: a study in smoking naive subjects. Am J Physiol Heart Circ Physiol. 2021 Jan 1;320(1):H144-H158. doi: 10.1152/ajpheart.00628.2020. Epub 2020 Nov 20.
- Wehrli FW, Caporale A, Langham MC, Chatterjee S. New Insights From MRI and Cell Biology Into the Acute Vascular-Metabolic Implications of Electronic Cigarette Vaping. Front Physiol. 2020 May 21;11:492. doi: 10.3389/fphys.2020.00492. eCollection 2020.
- Caporale A, Langham MC, Guo W, Johncola A, Chatterjee S, Wehrli FW. Acute Effects of Electronic Cigarette Aerosol Inhalation on Vascular Function Detected at Quantitative MRI. Radiology. 2019 Oct;293(1):97-106. doi: 10.1148/radiol.2019190562. Epub 2019 Aug 20.
- Chatterjee S, Tao JQ, Johncola A, Guo W, Caporale A, Langham MC, Wehrli FW. Acute exposure to e-cigarettes causes inflammation and pulmonary endothelial oxidative stress in nonsmoking, healthy young subjects. Am J Physiol Lung Cell Mol Physiol. 2019 Aug 1;317(2):L155-L166. doi: 10.1152/ajplung.00110.2019. Epub 2019 May 1.
- Caporale A, Lee H, Lei H, Rao H, Langham MC, Detre JA, Wu PH, Wehrli FW. Cerebral metabolic rate of oxygen during transition from wakefulness to sleep measured with high temporal resolution OxFlow MRI with concurrent EEG. J Cereb Blood Flow Metab. 2021 Apr;41(4):780-792. doi: 10.1177/0271678X20919287. Epub 2020 Jun 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 828195
- R01HL139358 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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